Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Iatrogenic Injury; Laryngeal Disease; Vocal Cord Paralysis; Globus Pharyngeus; Spasmodic Dysphonia; Larynx Paralysis; Presbylarynx; Aspiration; Sensory Neuropathy

Treatments: Other: Questionnaires; Procedure: Transnasal Laryngoscopy; Device: Cheung-Bearelly Aesthesiometer

Study type: Interventional

Funder types: Other

Identifiers

NCT06078527

232011

NCI-2023-10667 (Registry Identifier)

Details and patient eligibility

About

A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.

Full description

PRIMARY OBJECTIVES:

I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).

II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).

SECONDARY OBJECTIVES:

I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.

II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.

III. To assess patient reported outcomes (PROs).

EXPLORATORY OBJECTIVES:

I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:

• modified barium swallow (MBS) study kinematics;
• MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
• MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
• Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
• Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).

OUTLINE:

Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age <=18 years.
2. Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment
3. Ability and willingness to comply with study procedures.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

1. Non-English speaking.
2. Laryngopharyngeal structures are not accessible on exam.
3. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
4. Vocal fold immobility or severe hypomobility on adduction.
5. For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cancer Survivors

Experimental group

Description:

Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.

Treatment:

Device: Cheung-Bearelly Aesthesiometer

Procedure: Transnasal Laryngoscopy

Other: Questionnaires